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NCT02226341 · ClinicalTrials.gov registry record · Phase 4
ACTHar in the Treatment of Lupus Nephritis
A Phase 4 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT02226341: Clinical Trial Phase 4 study, sponsored by Columbia University.
NCT02226341 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02226341, a Phase 4 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the healthy cells and tissues, causing inflammation that can damage organs in the body. About 50% of SLE patients experience inflammation in the kidneys. The purpose of this study is to determine the effectiveness and safety of two dosing arms of ACTHar gel in treating proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar are safe and effective in treating proliferative LN (Class III and IV).
Primary Outcome
Complete response (CR) is defined as all of the following criteria having been achieved: 1. Stabilization of estimated glomerular filtration rate (eGFR) (i.e., a 6-month eGFR level ± 10% of baseline) or improvement if the screening value is changed from patient's baseline 2. Inactive urinary sediment (red blood cells per high-power field \[RBCs/HPF\] \< 5-10, not due to gyn bleeding) 3. Urine protein/creatinine ratio \< 0.5
Interventions
- DRUG CellCept
- DRUG ACTHar gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-10 |
| Est. Completion | 2024-01-03 |
| Phase | Phase 4 |
Why NCT02226341 stopped before completion
NCT02226341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which CellCept is the first listed.
NCT02226341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02226341 about?
NCT02226341 is a clinical study titled "ACTHar in the Treatment of Lupus Nephritis". Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the healthy cells and tissues, causing inflammation that can damage organs in the body. About 50% of SLE patients experience inflammation in the kidneys. The purpose of this study is to determine the effectiveness and...
What is the current status of trial NCT02226341?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2014-10. Estimated completion is 2024-01-03.
What interventions are being tested in trial NCT02226341?
The interventions under investigation include: CellCept (DRUG), ACTHar gel (DRUG).
Who is sponsoring clinical trial NCT02226341?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02226341's enrollment target sits among peer trials
8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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